SAN FRANCISCO and SUZHOU, China, July 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024 (NCT05458219).

旧金山和中国苏州，2024年7月1日/PRNewswire/--Innovent Biologics，Inc.（“Innovent”）（香港交易所：01801），一家世界级的生物制药公司，开发，制造和商业化用于治疗肿瘤学，心血管和代谢，自身免疫，眼科和其他主要疾病的高质量药物，宣布在2024年ESMO胃肠道癌症（ESMO GI）大会（NCT05458219）上口头介绍了用于治疗晚期胃/胃食管连接腺癌（G/GEJ AC）的创新抗CLDN18.2 ADC（IBI343）的最新1期临床数据。

The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2..

数据显示IBI343在肿瘤表达CLDN18.2的晚期胃癌患者中具有良好的疗效和良好的安全性。。

Gastric cancer is one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics[1], gastric cancer ranks as the 5th most common malignant tumor and the 5th leading cause of cancer death around the world. It accounts for an estimated 970,000 cases and 660,000 deaths worldwide.

胃癌是世界上最常见的恶性肿瘤之一。根据GLOBOCAN 2022年的统计数据（1），胃癌是全球第五大最常见的恶性肿瘤，也是全球第五大癌症死亡原因。据估计，全球约有970000例病例和660000例死亡。

Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of the global totals, respectively, highlighting a significant unmet medical need..

中国每年报告359000例新发胃癌病例和260000例胃癌死亡病例，分别占全球总数的37.0%和39.4%，突显出严重的医疗需求未得到满足。。

The data presented at this conference is from a Phase 1 study conducted in China and Australia with IBI343 and are as follows:

本次会议提供的数据来自中国和澳大利亚使用IBI343进行的第一阶段研究，如下所示：

In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%.

。在8 mg/kg剂量（N=17）下，ORR为47.1%，DCR为88.2%。

With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months.

6 mg/kg剂量组的中位随访时间为7.2个月，CLDN18.2高表达参与者的中位无进展生存期（mPFS）高达6.8个月。

The majority of treatment emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% patients had ≥ Grade 3 treatment-related adverse events (TRAEs). ≥ Grade 3 gastrointestinal toxicities were extremely low (<5%). No interstitial lung disease (ILD) occurred.

大多数治疗紧急不良事件（TEAE）为1-2级。在6 mg/kg剂量组中，31.6%的患者有≥3级治疗相关不良事件（TRAEs）。≥3级胃肠道毒性极低（<5%）。没有发生间质性肺病（ILD）。

Dr Jia (Jenny) Liu, translational lead of early phase clinical trials at The Kinghorn Cancer Centre, St Vincent's Hospital Sydney, said: 'As a next generation anti-CLDN18.2 antibody-drug conjugate that is Fc silenced, IBI343 has shown encouraging tolerability and clinical benefit in patients with advanced gastric and gastroesophageal junction adenocarcinomas that had moderate to high expression of CLDN18.2.

悉尼圣文森特医院金霍恩癌症中心早期临床试验的转化负责人贾（珍妮）刘博士说：“作为Fc沉默的下一代抗CLDN18.2抗体-药物偶联物，IBI343对CLDN18.2中度至高度表达的晚期胃和胃食管交界处腺癌患者表现出令人鼓舞的耐受性和临床益处。

Furthermore, the gastrointestinal toxicity of the drug we observed in the Phase 1 trial appears lower than that of other drugs targeting CLDN18.2, and there were no cases of interstitial lung disease. We look forward to seeing the results of ongoing Phase 3 trials comparing the efficacy and tolerability of IBI343 with standard-of-care treatments.'.

。我们期待着看到正在进行的3期临床试验的结果，比较IBI343与标准护理治疗的疗效和耐受性。”。

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, said, 'With a unique ADC platform designed to deliver effective and more tolerable therapeutics, the data in gastric cancer is a testimony to the molecular design of IBI343. We will further explore IBI343 in combination with other treatments, including immunotherapies, across different tumor types in order to benefit cancer patients worldwide.

Innovent Biologics高级副总裁周辉博士表示，“凭借独特的ADC平台，旨在提供有效且更耐受的治疗方法，胃癌数据证明了IBI343的分子设计。我们将进一步探索IBI343与其他治疗方法（包括免疫疗法）在不同肿瘤类型中的结合，以使全球癌症患者受益。

As a pioneer company in the field of oncology, Innovent is committed to advancing and promoting global innovation to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people.'.

作为肿瘤学领域的先驱公司，Innovent致力于推进和促进全球创新，以开发和商业化普通人负担得起的高质量生物制药。”。

Apart from gastric cancer, Innovent is also exploring IBI343's therapeutic potential in solid tumors such as pancreatic cancer. Earlier this month, the data from the Phase 1 clinical study of IBI343 in the treatment of patients with pancreatic cancer were presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, demonstrating encouraging efficacy and a favorable safety profile.

除胃癌外，Innovent还在探索IBI343在胰腺癌等实体瘤中的治疗潜力。。

[details link].

[详细信息链接]。

About Gastric/ Gastroesophageal Junction Adenocarcinoma

关于胃/胃食管交界处腺癌

Gastric cancer is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[2]. China and Japan have the highest incidence rates of gastric cancer[3]. Currently, the standard-of-care treatments for patients with advanced metastatic gastric cancer include a chemotherapy combination of fluoropyrimidine and platinum, as well as immune checkpoint inhibitor therapy.

。转移性胃癌患者的5年生存率低于5%[2]。中国和日本的胃癌发病率最高（3）。目前，晚期转移性胃癌患者的标准治疗包括氟嘧啶和铂的化疗组合，以及免疫检查点抑制剂治疗。

However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[4]..

然而，全身治疗对晚期胃癌的疗效有限。。这些患者的中位生存时间仅为0.5年左右。。

Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[5].

紧密连接分子家族的成员Claudin是上皮紧密连接的关键结构和功能成分。其中，CLDN18.2通常埋在胃粘膜中，但恶性肿瘤的发展导致紧密连接的破坏和肿瘤细胞膜上CLDN18.2表位的暴露（5）。

CLDN18.2 is expressed in up to 80% of patients with gastric cancer..

CLDN18.2在高达80%的胃癌患者中表达。。

About IBI343（Anti CLDN18.2 ADC）

关于IBI343（反CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells.

IBI343是由Innovent Biologics开发的重组人抗CLDN18.2单克隆抗体-药物偶联物（ADC）。IBI343与表达CLDN18.2的肿瘤细胞结合，将发生CLDN18.2依赖性ADC内化，并释放药物，导致DNA损伤并最终导致肿瘤细胞凋亡。

The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in 'bystander killing effect'..

释放的药物也可以扩散穿过质膜到达并杀死邻近的细胞，从而产生“旁观者杀伤效应”。。

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in this Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer.

作为一种创新的TOPO1i ADC，IBI343在这项1期临床研究中表现出可耐受的安全性和令人鼓舞的疗效信号。目前正在胃癌和胰腺癌等肿瘤类型中探索IBI343的治疗潜力。

In May 2024, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment.

2024年5月，中国国家医药产品监督管理局（NMPA）授予IBI343突破性治疗指定（BTD），作为CLDN18.2阳性胃或胃食管交界处（GEJ）腺癌患者的单一药物，这些患者在之前的两次全身治疗后经历了疾病进展。

The multi-center Phase 3 trial of IBI343 for this indication is in preparation. In June 2024, IBI343 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy..

IBI343针对该适应症的多中心3期临床试验正在准备中。2024年6月，IBI343获得美国食品和药物管理局（FDA）的快速通道指定，用于治疗复发和/或对先前一种治疗方案无效的晚期不可切除或转移性胰腺导管腺癌（PDAC）。。

About Innovent Biologics

关于Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

Innovent是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。。其开创性疗法治疗癌症，心血管和代谢，自身免疫和眼部疾病。

Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center..

。它有4个新药申请正在接受监管审查，4个资产在III期或关键临床试验中，另外18个分子在早期临床阶段。Innovent与30多家全球医疗保健公司合作，包括礼来、赛诺菲、Incyte、Adimab、LG Chem和MD安德森癌症中心。。

Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn..

Innovent秉承“从诚信做起，通过行动取得成功”的座右铭，保持行业实践的最高标准，并合作推进生物制药行业，使一流的药物可以广泛使用。有关更多信息，请访问www.innoventbio.com，或在Facebook和LinkedIn上关注Innovent。。

Disclaimer: Innovent does not recommend any unapproved drugs/indications.

免责声明：Innovent不推荐任何未经批准的药物/适应症。

Forward-Looking Statements

前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent Biologics, Inc. ('Innovent' or 'Company'), are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性声明，这些声明本质上具有重大风险和不确定性。。

The Company does not intend to update these forward-looking statements regularly..

公司不打算定期更新这些前瞻性声明。。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict.

这些前瞻性陈述是基于公司管理层在做出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并不能保证未来的发展，并受到风险、不确定性和其他因素的影响，其中一些因素超出了公司的控制范围，难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、公司竞争环境以及政治、经济、法律和社会条件的未来变化或发展，实际结果可能与前瞻性声明中包含的信息存在重大差异。。

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

公司、董事和员工不承担（a）纠正或更新本网站中包含的前瞻性声明的义务；。

References

参考文献

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

[1] Bray F，Laversanne M，Sung H等人，《2022年全球癌症统计数据：全球185个国家36种癌症的全球发病率和死亡率估计》。CA癌症J临床。2024年5月至6月；74（3）：229-263。

[2] Lasithiotakis K, Antoniou SA, Antoniou GA, Kaklamanos I, Zoras O. Gastrectomy for stage IV gastric cancer. a systematic review and meta-analysis. Anticancer Res. May 2014;34(5):2079-85

[2] Lasithiotakis K，Antoniou SA，Antoniou GA，Kaklamanos I，Zoras O.胃切除术治疗IV期胃癌。。抗癌研究2014年5月；34（5）：2079-85

[3] Xu B, Wang JM. Epidemiological study of gastric cancer[J]. Chin J Cancer Prev Treat, 2006,13(1): 81-87.

[3] 徐斌，王建民。胃癌流行病学研究[J]。Chin J Cancer Prev Treat，2006,13（1）：81-87。

[4] Chan WL, Lam KO, So TH, et al. Third-line systemic treatment in advanced/metastatic gastric cancer: a comprehensive review. Ther Adv Med Oncol. 2019;11:1758835919859990.

[4] Chan WL，Lam KO，So TH，et al。晚期/转移性胃癌的三线全身治疗：综述。Ther Adv Med Oncol。2019年；11： 1758835919859990年。

[5] Sahin U, Koslowski M, Dhaene K, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008;14(23):7624-7634.

[5] Sahin U，Koslowski M，Dhaene K等。Claudin-18剪接变体2是适用于治疗性抗体开发的泛癌靶标。Clin Cancer Res.2008；14（23）：7624-7634。

SOURCE Innovent Biologics

来源Innovent Biologics